Zogenix Painkiller Gets FDA Approval Despite Criticism

By Thomas M. Burton

The Food and Drug Administration on Friday approved an extended-release version of the narcotic painkiller hydrocodone despite a recommendation by its advisory committee that the drug should be rejected because of its potential for abuse.

The federal agency approved Zohydro ER from Zogenix Inc., the first hydrocodone product not mixed with milder painkillers such as acetaminophen and also the first extended-release hydrocodone product.

The federal agency said that because of the possibility of abuse, Zohydro ER should be reserved for patients who can’t tolerate other treatments or for cases in which the other treatments aren’t effective. The product will be a Schedule II controlled substance under federal drug laws, the most restrictive form of legally available prescription medicines.

The FDA action took place a day after it recommended imposing new restraints on the use of other hydrocodone-containing products. The agency said those products should also be categorized as Schedule II drugs, which can be supplied for no more than 90 days on a single prescription.

Last December, a panel of outside experts advising the FDA voted 11-2 not to recommend approval of Zohydro ER. The committee concluded that while the drug met targets for safety and efficacy, it could easily become a widely abused painkiller.

Zogenix said it is important to have a pure hydrocodone pill on the market without acetaminophen, because of that drug’s potential for liver damage if taken for a long time or at high doses. Acetaminophen overdose is a leading cause of liver failure in the U.S., it said.

Supporters of tighter curbs on opioid painkillers, who had praised the FDA on Thursday, called the new decision a setback.

Andrew Kolodny, president of Physicians for Responsible Opioid Prescribing, said, “The FDA just approved an extended release opioid that is likely to be neither safe nor effective in the target population. It is a whopping dose that can be lethal in someone who has never taken hydrocodone.”

Rep. William Keating (D., Mass.) said, “Just as the FDA was making some steps forward in the fight to end prescription drug abuse, they take major steps back with the approval of Zohydro ER.”

The FDA said that it approved the drug to give doctors an additional option to treat patients with acute pain and that it “shares the concerns about safe and appropriate use of extended release opioid analgesics.” The agency said a study will be conducted to assess the risk of abuse.